ASCO 2011 Genitourinary Cancers Symposium
ORLANDO — Dutasteride
increased adherence to active surveillance by nearly 40% in a cohort of men
with early stage prostate cancer, according to findings presented in advance of
the of the 2011 Genitourinary Cancers Symposium.
Neil Fleshner, MD, MPH, head of Urology at the
University Health Network in Toronto, Canada, presented data on behalf of the
Reduction with Dutasteride of Clinical Progression Events in Expectant
Management (REDEEM) study.
“We used this phase 3 multicenter study to see if
we could employ a commonly used drug to improve the compliance with active
surveillance for men who elect this as their strategy to manage early stage
prostate cancer,” Fleshner said. He noted that most of the men in this
particular population were not likely to die from their disease.
“Many men who choose active surveillance have
anxiety about disease progression,” he said. “We wanted to see if
this drug could improve that.”
There were 302 eligible men aged 48 to 82 involved in
the trial. Repeat 12-core biopsies were performed at 1.5 years and 3 years if
there was no cause and at other times if biopsy was warranted or desired.
“Some men simply no longer want to observe their cancer,” Fleshner
The primary endpoint was time to progression.
Pathological progression was defined as a Gleason score greater than 6, at
least 4 cores positive, or greater than 50% of any core positive. Therapeutic
progression was defined as radical prostatectomy, radiation therapy or hormonal
ablation, according to study results.
“Dutasteride (Avodart, GlaxoSmithKline) reduced the time to prostate cancer
progression by about 40%,” Fleshner said. He noted the relative risk
reduction of 38.9% (95% CI, 12.4%–57.4%). “This 40% reduction
significantly improves adherence to active surveillance.”
Fleshner said that 23% of men in the placebo group and
36% of men in the treatment group had no cancer detected in their final biopsy.
“There is no evidence of increased Gleason score
progression in the dutasteride arm compared to placebo,” he added.
“Drug-related adverse events were similar to those previously reported for
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